Events

Recall of BK Virus R-gene

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Biomerieux SA.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    20574
  • Event Initiated Date
    2016-08-29
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medi'Ray New Zealand Ltd, 53-55 Paul Matthews Road, Albany, Auckland 0632
  • Reason
    Following a customer compaint about difficulties to interpret low viral load in whole blood samples, an investigation showed that the sensitivity of the bk virus r-gene® claimed in the ifu for whole blood was not confirmed., the issue is only impacting whole blood samples with a low viral load, where amplification leads to creeping/flat curves difficult to interpret., this issue has no impact on negative results or on high positive samples, as the amplification curves are well identified.
  • Action
    Manufacturer to issue advice regarding use

Device

BK Virus R-gene
  • Model / Serial
    Model: 69-013B, Affected: Lot numbers: 1003909940 1004754140 and 1004764070
  • Manufacturer
    Biomerieux SA

Manufacturer

Biomerieux SA